Adherence to hormone therapy in patients with mCRPC: psychometric validation of the A-HT questionnaire.

Abstract: The incidence rate of prostate cancer (PCa) in many Western countries is high, contributing greatly to the cancer disease bur-den. In most cases, patients progress to metastatic disease defined as castration-resistant prostate cancer after androgen deprivation (mCRPC) following primary treatment where the majority of patients receive first-line new-generation oral hormonal therapies (HT) such as Abiraterone Acetate (AA) and Enzalutamide (ENZ). Despite the importance of correct intake of these drugs, adherence in patients with mCRPC is still poorly investigated and managed with measures not specific to this population. A self-report questionnaire was developed and validated with women with breast cancer treated with oral HT (A-BET). Therefore, this study aims to test the psychometric properties of this instrument on patients with mCRPC treated with AA or ENZ. A prospective observational validation study. The questionnaire was completed by all participants and again after 7/10 days by a randomized subsample to assess stability. Sixty-six patients completed the study (mean age of 72.8 years) and 31 completed the re-test (mean age of 72.7 years). Content validity reported excellent results. Cronbach's alpha of each item showed a strong correlation. Validation of an instrument to measure adherence to HT in patients with mCRPC can be a valuable tool for health professionals involved in patient care. In addition, having a population-specific validated instrument allows to make comparisons between results from different observations.

Adherence to endocrine therapy in women with breast cancer: development and preliminary validation of the A-BET questionnaire.

Purpose: To develop an Italian tool that measures the therapy adherence of women with breast cancer undergoing treatment with oral endocrine therapy. Methods: A two-phase study was conducted, which followed the guidelines of the European Statistical System for the development and validation of a questionnaire. In the first phase, the questionnaire was developed; in the second phase, a preliminary validation was carried out on patients with breast cancer undergoing treatment with oral hormonal therapies. Results: In its final version, the questionnaire presents 6 main items which aim to investigate the level of adherence, the degree of awareness of the nature of the drug taken and the reasons that may influence non-adherence. 82 patients were recruited in the validation study, with an average age of 56.4 years, while for the re-test 40 were selected with an average age of 57.3 years. Content validity reported excellent results. Cronbach's alpha of each item showed a strong degree of correlation. Conclusions: The creation of a tool for measuring adherence to endocrine therapy in breast cancer patients can be a valuable support for healthcare professionals involved in their care. Future studies should be aimed at using A-BET (Adherence - Breast Endocrine Therapy) on larger cohorts of patients in order to verify its validity / reliability more accurately and to be able to generalize the results.

Clinical presentation, genotype-phenotype correlations, and outcome of pancreatic neuroendocrine tumors in Von Hippel-Lindau syndrome.

PURPOSE: Data regarding the clinical management and follow-up of pancreatic neuroendocrine tumors (PanNETs) associated with Von Hippel-Lindau (VHL) syndrome are limited. This study aimed to assess clinical presentation, genotype-phenotype correlations, treatment and prognosis of PanNETs in a series of VHL syndrome patients. METHODS: Retrospective analysis of data of patients observed between 2005 and 2020. RESULTS: Seventeen patients, including 12 probands and 5 relatives (mean age 30.8 ± 18.4; 7 males), were recruited. PanNETs were found in 13/17 patients (77.5%) at a median age of 37 years: 4/13 (30.7%) at the time of VHL diagnosis and 9 (69.3%) during follow up. Six (46.1%) PanNET patients underwent surgery, whereas seven were conservatively treated (mean tumor diameter: 40 ± 10.9 vs. 15 ± 5.3 mm respectively). Four patients (30.7%) had lymph node metastases and a mean tumor diameter significantly larger than the nonmetastatic PanNETs (44.2 ± 9.3 vs. 17.4 ± 7 mm, p = 0.00049, respectively). Five (83.3%) operated patients had stable disease after a median follow up of 3 years whereas one patient showed liver metastases. Six (85.7%) non-resected PanNETs were stable after a median follow-up of 2 years, whereas one patient developed a new small PanNET and a slight increase in diameter of a pre-existing PanNET. No correlation was found between the type of germline mutation and malignant behavior of PanNETs. CONCLUSIONS: PanNETs are a common disease of the VHL syndrome and can be the presenting feature. Tumor size rather than genetic mutation is a prognostic factor of malignancy.

Propolis in the prevention of oral mucositis in breast cancer patients receiving adjuvant chemotherapy: A pilot randomised controlled trial.

Chemo-induced oral mucositis (OM) is associated with significant symptoms, treatment delays and increased costs. This pilot randomised controlled trial aimed at evaluating the safety, tolerability and compliance with propolis in breast cancer patients receiving doxorubicin and cyclophosphamide, testing preliminary clinical efficacy of propolis in the prevention of OM, and prospectively evaluating the incidence of OM. Sixty patients were randomised to receive either a dry extract of propolis with 8%-12% of galangin plus mouth rinsing with sodium bicarbonate (experimental arm), or mouth rinsing with sodium bicarbonate (control arm). OM was evaluated with the NCI-CTCAE v4.0 after 5, 10, 15 and 21 days of treatment. Compliance with, tolerability of propolis and adverse events were recorded. The incidence of OM was also prospectively evaluated for 6 months. Two patients (6.7%) manifested a suspected skin reaction to propolis. No patient in the experimental arm developed OM > G1, while in the control arm OM > G1 was 16.7% (p = .02). The incidence of OM ≥ G1 at the end of cycles 2-8 was higher at the second (25%) and fifth cycles (45.8%). Propolis plus bicarbonate was safe, well tolerated and promisingly effective in the prevention of OM in patients with breast cancer.

The experiences of protective isolation in patients undergoing bone marrow or haematopoietic stem cell transplantation: systematic review and metasynthesis.

Protective isolation is aimed at preventing infection in neutropenic patients, but it is implemented inconsistently across centres and is supported by recommendations with poor evidence. This review and metasynthesis explored the experiences and the psychological implications of protective isolation in patients with haematological malignancies undergoing bone marrow (BMT) or haematopoietic stem cell transplantation (HSCT). A systematic search of multiple databases for qualitative studies exploring BMT or HSCT patients' experiences of protective isolation was completed. The metasynthesis followed the meta-aggregative method from the Joanna Briggs Institute, with four procedural steps: (1) comprehensive search, (2) quality appraisal, (3) extraction of relevant findings and (4) synthesis of the identified findings. Twenty-six findings were extracted from 11 articles included in the review. The synthesising process yielded seven categories, aggregated into three synthesised findings: (1) isolation is a source of suffering, (2) isolation can lead to relating with oneself and (3) the person does not close the door to the outside world. This metasynthesis sheds light on patients' suffering from being isolated, and the possibility of overcoming this suffering thanks to relationships that patients have with themselves and with the external world. Healthcare providers should reconsider this practise in order to avoid unnecessary patient suffering.

Features and organization of Pain Centers in the Lazio Region, Italy, in 2011.

BACKGROUND: Evidence on pain management highlights the importance of a multidisciplinary approach in order to achieve optimal therapeutic results. Such programs can be guaranteed by the Centers for Pain Management (CPMs), in which multidisciplinary teams are able to provide advanced and specialized activities for the assessment, diagnosis and treatment of chronic benign pain. To date, information related to healthcare supply and the organizational structure of these centers in Italy is incomplete. The aim of this paper was to provide an overview of the healthcare network of the CPMs in the Lazio region. METHODS: A descriptive survey was conducted in all the 37 CPMs existing in the Lazio region in 2011 of which 28 participated. RESULTS: CPMs were located either in Universities or in public or private hospital facilities. They included a clinic, a Day Hospital service, Day surgery and day-beds. CPMs were managed by anaesthesiologists who, in most instances, did not work in a multidisciplinary team. The number of other health professionals available, such as nurses, psychologists and physiotherapists, was limited. CPMs mainly provided drug therapy, Complementary Alternative Medicine (CAM) and complex interventional treatments. The median waiting time was 30 days. The clinics were not homogeneously distributed in the region with a higher concentration in Rome (56%), followed by other provinces of the Lazio region (26%) and the province of Rome (18%). Clearly, Rome was the city which offered the greatest range of healthcare services and the highest number of consultations with patients, which significantly differed from those of the other areas (χ²=19.6 p<0.01). CONCLUSIONS: In 2011, the availability of CPMs was not equally distributed throughout the territory, and there was an over-utilization of the facilities in Rome and an under-utilization in the provincial areas. Moreover, this study showed a lack of a multi-professional approach to chronic pain management.

Pressure ulcers in cancer palliative care patients.

Terminally ill cancer patients are considered at high risk for pressure ulcers because of their clinical condition. However, in Italy, data about pressure ulcers and their prevalence are insufficient. This paper reports a study on pressure ulcers incidence and prevalence in a population of oncology patients cared for in an Italian palliative care service. A retrospective analysis of 414 clinical records of patients admitted over 6 months showed a prevalence of pressure ulcers of 22.9% and an incidence of 6.7%. Karnofsky Performance Scale Index scores, age and length of the stay were significantly related to the pressure sore development. These results support the need to focus attention on pressure ulcers prevention and treatment in terminally ill cancer patients, and to further define specific guidelines aimed at warranting patients' comfort and quality of life.

[Risk management: relationship with the patient's relatives, who does what?]. / Gestione del rischio: rapporto con i familiari, chi fa cosa?

Risk management is the systematic process of identification, evaluation and treatment of current and potential risks. In the last decades it has acquired a significant importance also in the medical field, where it aims to increase patient' safety, to reduce adverse events and costs, thus improving patients' outcomes. Gastrointestinal endoscopy is a clinical field where operative procedures are carried out; some of them may have complications, which can lead to legal cases; among such techniques endoscopic ultrasonography is acceptably safe. The aim of the article is to highlight some aspects of the risk management which are related with the patient's relatives, in the field of endoscopic ultrasonography: from the gathering of the case history to the required information for a safe discharge. Communication skills and attention given to the information process, can allow the reduction of clinical risks for patients undergoing endoscopic procedures.

Plasminogen activator inhibitor-1 and carotid intima-media thickening in patients with newly detected primary hypertension.

OBJECTIVE: To investigate the correlation between ultrasonographically evaluated intima-media thickness (IMT) of common carotid artery (CCA) and cardiovascular risk factors for subjects with newly detected, uncomplicated and untreated primary hypertension. METHODS: The study population consisted of 200 subjects (123 men and 77 women, aged 46+/-7.5 years). Blood pressure was measured in the clinical setting and by 24 h noninvasive ambulatory monitoring. Fasting levels of blood glucose, plasma lipids and lipoproteins, fibrinogen and plasminogen activator inhibitor (PAI)-1 were measured. Ultrasound examination included measurement of far-wall intima-media complex of CCA and morphologic evaluation of occurrence of plaques in carotid and femoral bifurcations. RESULTS: The prevalence of greater than normal IMT (mean IMT > or =0.80 mm) was 22%. Significant univariate correlations to the dichotomy between normal and greater than normal mean IMT were detected for age, smoking, level of LDL cholesterol, level of PAI-1 and total ultrasonographic score. Multivariate logistic regression analysis confirmed the associations between greater than normal mean IMT and plasma concentrations of LDL cholesterol and PAI-1 as well as total ultrasonographic score. CONCLUSION: Greater than normal IMT of CCA was more strictly related to other cardiovascular risk factors than it was to blood pressure and was strongly associated with the occurrence of atherosclerotic plaques in carotid and femoral arteries. The role of PAI-1 in intima-media thickening that is emerging suggests that fibrinolytic balance is an important determinant of vessel-wall homeostasis in hypertensive patients.